# K181369: Immucise Intradermal Injection System

- Pathway: 510(k) (Traditional)
- Applicant: Terumo Corporation
- Decided: Nov 13, 2018 after 174 days
- Product code: FMI (Needle, Hypodermic, Single Lumen)
- Device class: 2
- Regulation: 21 CFR 880.5570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K771205 (1977). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052034: Terumo Syringe with/Without Needle, Terumo Medical Corp. (2005) Summary page 5.
- K123588: Intradermal Adapter, West Pharmaceutical Services, Inc. (2013) Summary page 5.

## Most influential descendants
- K190427: Immucise (2019), 0 descendants of its own

## Indications for use
The Immucise Intradermal Injection System is indicated for intradermal injections of FDA approved drugs. The system is to be used in the deltoid region for adults.

Source page: https://510kreport.com/device/K181369
Methodology: https://510kreport.com/methodology